Fremont, CA, 94536, USA
1 day ago
Quality Assurance Analyst
Description We are seeking an experienced and detail-oriented QA Support detail oriented to provide critical support to our CMC group. This role is essential for ensuring the quality and compliance of our products as we experience significant growth and expansion. The ideal candidate will have a strong background in QA within the pharmaceutical industry, particularly with batch record review and experience supporting manufacturing, validations, and tech transfer activities. Responsibilities: Provide day-to-day QA support for the CMC group. Oversee QA analytical processes related to CMC. Support manufacturing, validation, and tech transfer activities. Thoroughly review batch records, protocols, reports, Certificates of Analysis (COA), and Certificates of Compliance (COC). Manage documentation and release processes. Collaborate effectively with cross-functional teams. Assist with other related QA tasks as needed. Requirements Experience: 7+ years in the industry (flexible). Skills & Background: Strong batch record review experience. CMC experience is a plus. Expertise in dosage, batch release, and validation protocols. Hands-on experience with tech transfers (drug substance & drug product manufacturing). Ability to review batch records, release documentation, and COC. Tools: Veeva experience is a plus (training available if needed). Technology Doesn't Change the World, People Do.® Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles. Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more. All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information. © 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use (https://www.roberthalf.com/us/en/terms) .
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